Quality Engineer III

Design Quality Engineer III

Location: Maple Grove, MN 55311 Onsite Duration: 12+ Months Payrate: $50.00 - $54.58/HR. on W2

Core Responsibilities

• Support and lead Design History File (DHF) Remediation activities for sustaining medical device products.
• Perform gap assessments, evidence collection, documentation updates, and design control remediation.
• Create/update:
  • Design Inputs & Outputs
  • Product Specifications
  • Component Specifications
  • Engineering Drawings/Prints
  • Design Review Documentation
  • Verification & Validation (V&V) Traceability
• Maintain end-to-end traceability between:
  • Design Inputs
  • Design Outputs
  • Risk Controls
  • Verification
  • Validation
• Lead updates to DFMEA and Hazard Analysis documentation.
• Support audit/inspection readiness and regulatory compliance.
• Collaborate with R&D, Manufacturing, Regulatory Affairs (RA), Document Control, and Quality teams.

Must-Have Skills

• 3+ years of Medical Device Industry experience.
• Strong knowledge of Design Controls.
• Experience with:
  • Design History Files (DHF)
  • Design Inputs/Outputs
  • Product Specifications
  • Component Specifications
  • Engineering Drawings/Prints
• Experience maintaining:
  • DFMEA
  • Hazard Analysis
  • Risk Management Documentation
• Understanding of:
  • Verification & Validation (V&V)
  • Traceability Matrices
  • FDA/ISO Medical Device Design Control Requirements